U.S. patent application number 10/829019 was filed with the patent office on 2004-10-28 for method and device for use in tissue approximation and fixation.
Invention is credited to Gannoe, Jamy, Gerbi, Craig, Mata, Gilbert JR., Scott, J. Stephen, Sutton, Douglas S., Weller, Gary.
Application Number | 20040215216 10/829019 |
Document ID | / |
Family ID | 29999507 |
Filed Date | 2004-10-28 |
United States Patent
Application |
20040215216 |
Kind Code |
A1 |
Gannoe, Jamy ; et
al. |
October 28, 2004 |
Method and device for use in tissue approximation and fixation
Abstract
Methods and devices for use in tissue approximation and fixation
are described herein. The present invention provides, in part,
methods and devices for acquiring tissue folds from the anterior
and posterior portions of a hollow body organ, e.g., a stomach,
positioning the tissue folds for affixing within a fixation zone of
the stomach, preferably to create a pouch or partition below the
esophagus, and fastening the tissue folds such that a tissue bridge
forms excluding the pouch from the greater stomach cavity. The
present invention further provides devices for performing a
transoral, endoscopic hollow organ division, including a tissue
acquisition device capable of acquiring the desired tissue, a
tensioning device for positioning the acquired tissue, and a
fastening element to secure the outer layers of the acquired tissue
such that the desired healing response is achieved.
Inventors: |
Gannoe, Jamy; (Redwood City,
CA) ; Weller, Gary; (Los Gatos, CA) ; Gerbi,
Craig; (Mountain View, CA) ; Sutton, Douglas S.;
(Pacifica, CA) ; Mata, Gilbert JR.; (Tracy,
CA) ; Scott, J. Stephen; (St. Charles, MO) |
Correspondence
Address: |
MORRISON & FOERSTER LLP
755 PAGE MILL RD
PALO ALTO
CA
94304-1018
US
|
Family ID: |
29999507 |
Appl. No.: |
10/829019 |
Filed: |
April 20, 2004 |
Related U.S. Patent Documents
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Application
Number |
Filing Date |
Patent Number |
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10829019 |
Apr 20, 2004 |
|
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10188547 |
Jul 2, 2002 |
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6773440 |
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Current U.S.
Class: |
606/151 |
Current CPC
Class: |
A61B 17/064 20130101;
A61B 2017/081 20130101; A61B 17/068 20130101; A61B 2017/0647
20130101; A61B 17/29 20130101; A61B 2017/2944 20130101; A61B
17/0643 20130101; A61B 2017/2929 20130101; A61B 17/30 20130101;
A61B 2017/306 20130101; A61B 2017/00561 20130101; A61B 2017/00827
20130101; A61B 17/00234 20130101; A61F 5/0086 20130101 |
Class at
Publication: |
606/151 |
International
Class: |
A61B 017/08 |
Claims
We claim:
1. A tissue acquisition device, comprising: an elongate main body
having a proximal end, a distal end, and a length therebetween; a
first jaw member and a second jaw member each pivotally connected
to the distal end of the main body, wherein the first and the
second jaw members are adapted to move from a first configuration
to a second expanded configuration in which the jaw members are
translationally positioned into apposition with each other, and
wherein the first and the second jaw members each define an opening
for acquiring tissue therewithin, each opening being in fluid
communication with at least one lumen defined in the main body.
2. The device of claim 1 wherein the main body defines additional
lumens within the length.
3. The device of claim 1 further comprising at least one wire
disposed within the main body for reinforcing the main body.
4. The device of claim 1 further comprising at least one pull wire
disposed within the main body and attached along the length for
selectively articulating the device.
5. The device of claim 1 further comprising at least one push rod
disposed within the main body and attached along the length for
selectively articulating the device.
6. The device of claim 1 further comprising a handle attached to
the proximal end of the main body, the handle defining a main port
therethrough which is in communication with the at least one lumen
defined in the main body.
7. The device of claim 6 wherein the handle further comprises a
lever for actuating the first and the second jaw member in a
scissoring motion.
8. The device of claim 1 wherein the first and the second jaw
members are connected to the main body via first and second hinging
members, respectively.
9. The device of claim 8 wherein each hinging member comprises two
crescent-shaped cutaways spaced longitudinally along the length of
the main body at 180.degree. from one another.
10. The device of claim 1 wherein each opening on the first and the
second jaw members are each defined at 180.degree. from one
another.
11. The device of claim 1 wherein each opening has a length of
about 1 in. longitudinally along each jaw member.
12. The device of claim 1 wherein each opening extends about 0-5
cm. into each jaw member.
13. The device of claim 1 further comprising at least one guide rod
affixed to at least the first or the second jaw member, wherein the
guide rod is adapted to tension the tissue when acquired within the
opening.
14. The device of claim 13 wherein the guide rod comprises a rigid
bar member affixed to the first and the second jaw member.
15. The device of claim 13 wherein the guide rod is curved to
extend longitudinally adjacent to the first or the second jaw
member.
16. The device of claim 1 further comprising a mechanical post
adapted to be inserted down the lumen of the main body for securing
the tissue.
17. The device of claim 1 further comprising a fastening assembly
having a handle, a delivery body, and a clamping portion with
clamping jaws attached to a distal end of the delivery body, the
fastening assembly being adapted to be inserted through the main
body.
18. The device of claim 17 further comprising at least one
fastening element releasably disposed within the clamping jaws.
19. The device of claim 18 wherein the fastening element comprises
a staple.
20. The device of claim 18 wherein the fastening element comprises
a rivet and a receiving rivet portion for attachably receiving the
rivet.
21. The device of claim 18 wherein the fastening element comprises
an implantable clamp having a penetrating clamp portion for
interfacing with a receiving clamp portion.
22. The device of claim 21 wherein the penetrating clamp portion
comprises a patterned or textured tissue engagement surface.
23. The device of claim 21 wherein the receiving clamp portion
comprises a patterned or textured tissue engagement surface.
24. The device of claim 21 wherein the implantable clamp has a
curved configuration.
25. The device of claim 21 wherein the implantable clamp further
comprises a hinge pivotally connecting the penetrating clamp
portion to the receiving clamp portion.
26. The device of claim 18 wherein the fastening element is
comprised of a material adapted to assist in tissue ingrowth and
healing.
27. The device of claim 26 wherein the material is selected from
the group consisting of meshes, grafts, microporous membranes, and
biomaterials, collagen, and porcine biointestinal submucosa.
28. The device of claim 1 wherein the opening in the first and the
second jaw members comprise a plurality of fenestrations defined
along each of the jaw members.
29. The device of claim 1 wherein the opening in the first and the
second jaw members comprise at least one fenestration.
Description
CROSS-REFERENCE TO RELATED APPLICATIONS
[0001] This application is a divisional of U.S. patent application
Ser. No. 10/188,547 filed Jul. 2, 2002, which is incorporated
herein by reference in its entirety.
FIELD OF THE INVENTION
[0002] The present invention relates generally to medical apparatus
and methods and more particularly to devices and methods for
dividing a hollow body organ or otherwise restricting or
partitioning a certain section of that organ, particularly a
stomach, intestine or gastrointestinal tract for purposes of
reducing the volume of the hollow body organ. In addition, such
tools and techniques may be used to exclude specified tissue
sections within a hollow body organ either to reduce volume, or to
exclude the portion of tissue that is clinically undesirable, such
as in the case of gastroesophogeal reflux disease (GERD) or
exclusion of certain sections of the stomach relating to the nuero
hormonal pathways for hunger. These devices may be used alone or in
conjunction with each other and may be permanently implanted, or
removed once they have served their purpose, e.g., the desired
tissue effect has occurred (healing), or the clinical benefit has
been achieved, for example, the patient has lost the directed or
desired amount of weight, or the patient is no longer experiencing
reflux.
BACKGROUND OF THE INVENTION
[0003] In cases of severe obesity, patients may currently undergo
several types of surgery either to tie off or staple portions of
the large or small intestine or stomach, and/or to bypass portions
of the same to reduce the amount of food desired by the patient,
and the amount absorbed by the gastrointestinal tract. The
procedures currently available include laparoscopic banding, where
a device is used to "tie off" or constrict a portion of the
stomach, vertical banded gastroplasty (VBG), or a more invasive
surgical procedure known as a Roux-En-Y gastric bypass to effect
permanent surgical reduction of the stomach's volume and subsequent
bypass of the intestine.
[0004] Typically, these stomach reduction procedures are performed
surgically through an open incision and staples or sutures are
applied externally to the stomach or hollow body organ. Such
procedures can also be performed laparoscopically, through the use
of smaller incisions, or ports, through trocars and other
specialized devices. In the case of laparoscopic banding, an
adjustable band is placed around the proximal section of the
stomach reaching from the lesser curve (LC) of the stomach around
to the greater curve (GC), thereby creating a constriction or
"waist" in a vertical manner between the esophagus (ES) and the
pylorus (PY) (See Prior Art FIG. 1). During a VBG (See Prior Art
FIG. 2) a small pouch (P) (approximately 20 cc in volume) is
constructed by forming a vertical partition from the
gastroesophageal junction (GEJ) to midway down the lesser curvature
of the stomach by externally applying staples, and optionally
dividing or resecting a portion of the stomach, followed by
creation of a stoma (ST) at the outlet of the partition to prevent
dilation of the outlet channel and restrict intake. In a Roux-En-Y
gastric bypass (see Prior Art FIG. 3), the stomach is surgically
divided into a smaller upper pouch connected to the esophageal
inflow, and a lower portion, detached from the upper pouch but
still connected to the intestinal tract for purposes of secreting
digestive juices. A resected portion of the small intestine is then
anastomosed using an end-to-side anastomosis to the upper pouch,
thereby bypassing the majority of the intestine and reducing
absorption of caloric intake and causing rapid "dumping" of highly
caloric or "junk foods".
[0005] Although the outcome of these stomach reduction surgeries
leads to patient weight loss because patients are physically forced
to eat less due to the reduced size of their stomach, several
limitations exist due to the invasiveness of the procedures,
including time, general anesthesia, healing of the incisions and
other complications attendant to major surgery. In addition, these
procedures are only available to a small segment of the obese
population (morbid obesity, Body Mass Index .gtoreq.40) due to
their complications, leaving patients who are considered obese or
moderately obese with few, if any, interventional options.
[0006] In addition to surgical procedures, certain tools exist for
approximating or otherwise securing tissue such as the stapling
devices used in the above-described surgical procedures and others
such as in the treatment of gastroesophogeal reflux (GERD). These
devices include the GIA.RTM. device (Gastrointestinal Anastomosis
device manufactured by Ethicon Endosurgery, Inc. and a similar
product by USSC), and certain clamping and stapling devices as
described in U.S. pat. Nos. 5,897,562 and 5,571,116 and 5,676,674,
Non-Invasive Apparatus for Treatment of Gastroesophageal Reflux
Disease (Bolanos, et al) and Pat. No. 5,403,326 Method for
Performing a Gastric Wrap of the Esophagus for Use in the Treatment
of Esophageal Reflux (Harrison et al) for methods and devices for
fundoplication of the stomach to the esophagus for treatment of
gastro esophageal reflux (GERD). In addition, certain tools as
described in U.S. Pat. No. 5,788,715 Telescoping Serial Elastic
Band Ligator (Watson et al), U.S. Pat. No. 5,947,983 Tissue Cutting
and Stitching Device and Method (Solar et al) detail an endoscopic
suturing device that is inserted through an endoscope and placed at
the site where the esophagus and the stomach meet. Vacuum is then
applied to acquire the adjacent tissue, and a series of stitches
are placed to create a pleat in the sphincter to reduce the
backflow of acid from the stomach up through the esophagus. These
devices can also be used transorally for the endoscopic treatment
of esophageal varices (dilated blood vessels within the wall of the
esophagus).
[0007] Further, certain devices are employed to approximate tissue
such as in bowel anastomosis, via traditional suturing or stapling,
or employing tools such as the commercially available Valtrac
(Devis & Geck Company) and the AKA 2 (see British Journal of
Surgery, Vol 87, Iss 8, Page 1071, August 2000), which are circular
clamping devices used to affect "compression anastomosis" (e.g.
once sufficient clamping force is applied, tissue of the bowel
heals together and the device is no longer essential to the joining
of the tissue). See also U.S. Pat. No. 5,250,058 Absorbable
Anastomotic Fastener Means (Miller et al) and U.S. Pat. No.
5,697,943 Apparatus and Method for Performing Compressional
Anastomosis (Sauer et al) and PCT Publication No. WO 99/17662
Anastomosis Ring Insertion Device (Phillips et al).
[0008] There is a need for improved devices and procedures. In
addition, because of the invasiveness of most of the surgeries used
to treat obesity, and the limited success of others, there remains
a need for improved devices and methods for more effective, less
invasive hollow organ restriction procedures.
SUMMARY OF THE INVENTION
[0009] The present invention provides for improved methods and
apparatus for the transoral, or endoscopic, division of a hollow
body organ, such as the creation of a small stomach pouch. In the
case of the present invention, the surgeon or endoscopist may
insert devices as described below through the patient's mouth, down
the esophagus and into the stomach or intestine as appropriate. The
procedure can be performed entirely from within the patient's
stomach or other organ, and does not require any external incision.
The end result of the procedure is the formation of a variety of
organ divisions or plications that serve as barriers or
"partitions" or "pouches" that are substantially sealed off from
the majority of the organ cavity. For example, in the case of
dividing the stomach, the "pouch" or partitions that are created
may seal a small portion of the stomach just below the esophagus to
allow only small amounts of food or liquid to be consumed by the
patient. This pouch or partition will mimic the section of stomach
sealed off from the majority of the organ in a traditional obesity
surgery heretofore described; however, it can be formed and secured
entirely from inside the stomach endoscopically, obviating the need
for a prolonged procedure, external incisions, and in some cases,
general anesthesia.
[0010] The methods and tools of the present invention may also be
used in treating GERD in that stomach folds just below the
esophagus can be acquired and fastened to create a desired "pleat",
thereby effectively extending the length of the esophagus and
preventing reflux. A single fold of tissue, or a dual fold of
tissue can be acquired. Further, features of the present invention
would assist in the longevity of the GE Junction (GEJ)/Esophageal
pleat as compared to current devices and techniques as the
plication would include a more significant amount of muscular
tissue. In addition, the devices and methods of the present
invention may be used to revise or repair failures seen in current
surgical procedures, such as dilation of the pouch and/or stoma
(stomata) formed in a traditional Roux-En-Y gastric bypass, or VBG.
In these cases, when the stoma dilates or shifts, the tools of the
present invention would be useful to apply pleats at the site of
dilation to narrow it, thereby making the stoma functional again,
or by further reducing the volume of an existing pouch which has
dilated.
[0011] The devices shown and described herein can be used to form a
pouch or partition by the approximation and fixation of two folds
of organ tissue, one fold created in the anterior wall of the
organ, and one fold created in the posterior wall of the organ
using a tissue acquisition device inserted minimally invasively or
transorally into the target organ, e.g., the stomach. A calibration
balloon on the end of the tissue acquisition device may also be
employed to size the pouch or partition and to position the tools
correctly to determine where the folds will be created.
Alternatively, the tissue acquisition device may be adapted to
receive a standard endoscope to allow viewing of the target region
at various points during the procedure.
[0012] The devices shown and described herein can also create the
tissue folds using vacuum to acquire tissue from both walls using
an endoscopic tissue acquisition device having windows or openings
spaced apart from each other, preferably 180 degrees from one
another. Once the tissue folds are acquired, an optional mechanical
retraction/tensioning mechanism may be employed to engage and
tension the folds within the tissue acquisition device. Said
mechanical retraction or tensioning mechanism securely approximates
the tissue folds such that a consistent and substantial fold of
muscular tissue is presented for fixing the tissue folds
together.
[0013] A fastening element or fastening assembly may also be
employed to secure the tissue folds and create the division or
divisions within the organ. Additionally, it may be preferable for
the fastening assembly to clamp the tissue folds together prior to
delivering the fastening elements to enhance the durability of the
fastened section.
[0014] In similar fashion, a tissue acquisition device may be
employed to secure tissue together, either in a dual fold
(acquisition of a fold from both the anterior and posterior side of
the organ), or single fold configuration (acquisition of one fold
of tissue), at the GEJ to create an effective lengthening of the
esophagus for treatment of GERD. A single or dual fold of tissue
may be acquired at the cardiac notch (portion between the GEJ and
the esophagus of the patient) and fastened to form a staple line
parallel to the LC of the stomach.
[0015] Several aspects of the present invention were arrived at
after experimentation with stomach and other body tissue and the
challenges of acquiring and securing such tissue reliably. In
particular, it is preferable for the device of the present
invention to consistently approximate the tissue and tension it
such that when the fixation elements or fasteners of the present
invention are delivered, they consistently reach the outer fibrous
layers of the organ wall, such as the muscularis and serosa of the
stomach. Once these fibrous layers are secured appropriately
according to the present invention, they will adhere, fuse or scar
over to affect the desired fastening of the tissue folds. The
devices of the present invention will likely need to maintain
apposition of the two folds for 24 weeks, but that fusion of the
tissue may take place as soon as 5-10 days following the procedure,
or as long as 8-10 weeks. If tissue folds are secured
inconsistently, or if insufficient compression is applied at the
time of securement, complications such as rapid ischemic necrosis,
gastric erosion, ulceration, and failure of the secured walls may
result.
[0016] Various devices and methods for securing the tissue folds
once they are approximated, may also include a stapling device,
clamp or other fasteners. The fastening assembly may further be a
flexible endoscopic stapler device, capable of being deployed
within the lumen of the tissue acquisition device once the tissue
folds are tensioned, said stapler then rotationally or
longitudinally adjusted or automatically aligned within the tissue
acquisition device to ensure correct alignment with the tissue
folds, and clamped to deploy a staple line. This stapler is
preferably deployed with force sufficient to displace much of the
mucosal tissue out of the targeted fixation region prior to
securing the two tissue folds together. A clamp device may be
alternatively deployed instead of a staple to achieve both the
clamping function and the fixation function. Said clamp device may
include teeth or treads to allow tissue perfusion and cell growth
for healing at the fixation region once the clamp is deployed.
Fasteners such as rivets or clips may be deployed to secure the
tissue.
[0017] Any of the fastening devices described herein may be
bioabsorbable or biofragmentable, such that once the desired tissue
healing has occurred, they dissolve or otherwise degrade leaving
only the fixation region, now a tissue "bridge" (TB) sufficiently
adhered or healed together to maintain the integrity of the pouch
or partition, similar in some ways to the compression anastomosis
tools referred to above. In addition, they may include coatings or
other secondary features to aid healing, such as resorbable meshes,
surgical felt, or tissue grafts.
[0018] The procedure of the present invention may be permanent in
that the pouch or partitions would restrict the stomach
indefinitely, or may be reversible (once weight loss is achieved,
or reflux minimized) or revised (in the event pouch side needs to
be modified). Further, if the physician so desires, techniques of
the present invention may be augmented or assisted by the use of
other techniques such as laparoscopy. Optionally, techniques of the
present invention may be combined with other procedures such as the
treatment of GERD or the transoral placement of a bypass prosthesis
or other type of liner in the intestine to bypass of the hormonally
active portion of the small intestine.
BRIEF DESCRIPTION OF THE DRAWINGS
[0019] FIG. 1 depicts the prior art procedure commonly known as
laparoscopic banding;
[0020] FIG. 2 depicts the prior art procedure commonly known as the
vertical banded gastroplasty or "VBG";
[0021] FIG. 3 depicts the prior art procedure commonly know as
surgical Roux En Y procedure;
[0022] FIGS. 4A-4H depict schematic drawings of the objects of the
present invention for dividing and restricting, or partitioning a
hollow body organ, namely the stomach as viewed from outside and
inside the organ;
[0023] FIG. 5 shows a schematic depiction of a cross section of two
tissue folds (anterior and posterior stomach wall) as they would be
acquired and tensioned by the tissue acquisition device of the
present invention (devices deleted for clarity);
[0024] FIG. 6 depicts a cross sectional view of the clamping of the
two tissue folds to ensure approximation of the fibrous tissue
layers, and the positioning of a clamp or fastener of the present
invention;
[0025] FIG. 7 depicts a cross section of the divided organ, showing
the pouch excluded from the majority of the organ cavity by a
healed in tissue bridge as constructed by the present
invention;
[0026] FIGS. 8, 8A, 8B, 9, 9A, 10, 11, 11A and 11B depict an
example of sequential procedural steps for performing an organ
division or restriction as taught by the present invention.
Restriction of the stomach is used for illustrative purposes;
[0027] FIGS. 12, 12A, 12B and 12C depict one embodiment of a tissue
acquisition device of the present invention, including detail on an
articulating feature used as a tensioning device to further
approximate the acquired tissue folds;
[0028] FIG. 13 depicts another embodiment of a tissue acquisition
and tensioning device of the present invention;
[0029] FIG. 14 depicts another embodiment of a tissue acquisition
and tensioning device of the present invention (only one arm of the
device is shown for clarity);
[0030] FIGS. 15 and 15A depict a fastening assembly of the present
invention, including a clamping device and a fastening device.
[0031] FIG. 16 depicts the operation of the fastening assembly of
FIG. 15 through the tissue acquisition device (distal end omitted
for clarity) to clamp and fasten tissue folds as taught by the
present invention;
[0032] FIG. 17 depicts one embodiment of a fastening device of the
present invention;
[0033] FIGS. 18A and 18B depict another embodiment of a fastening
device of the present invention in an undeployed and deploying
configuration;
[0034] FIG. 19 depicts yet another embodiment of a fastening device
of the present invention;
[0035] FIGS. 20A and 20B depict a cross sectional, perspective view
of representative fastening devices of the present invention
deployed to approximate two tissue folds of a target organ to be
divided or restricted.
DETAILED DESCRIPTION OF THE INVENTION
[0036] The present invention provides, in part, for methods and
devices for hollow organ division and restriction, more
particularly providing methods and devices to perform a transoral,
endoscopically mediated stomach reduction for purposes of, e.g.,
treating obesity.
[0037] As previously discussed, the results of some clinical
procedures of the prior art are shown in FIGS. 1-3, from a
perspective external to the stomach. An example of a result of the
procedure in one embodiment of the present invention is shown in
FIG. 4A, depicting an external anterior view of a stomach organ
400, having an esophagus 410 (cut away to reveal the esophageal
lumen 420), and further depicting a fastening line, or staple line
430, producing a pouch (P). Fastening line 430 is preferably
positioned as close to the gastroesophageal junction (GEJ) at the
base of the esophagus, and angled toward the lesser curve of the
stomach (LC), leaving an approximate 1 cm gap between the LC and
the end of fastening line. This gap, or stoma 440, operates to
restrict food from emptying from the pouch, while still allowing
communication between the pouch and the greater stomach volume for
purposes of passage of digestive fluids and secretions. FIG. 4B
depicts the organ division of FIG. 4A as a transparent section to
further depict the cross section of the resulting division (pouch
"P") created by fastening line 430 at section line S.
[0038] FIGS. 4C-4H represent alternative placements of the
fastening line 430 to achieve various configurations of organ
division, each having a potential clinical application depending on
the preference of the physician and clinical needs of the patient.
FIG. 4C depicts the same organ model as described in FIG. 4A, but
with a plurality of fastening lines 430 placed in a funnel
configuration to create partitions in the organ that form a pouch P
between the fastening lines. In this embodiment, it may be
desirable to leave several stomas or openings 440 to assist in
organ function (e.g. digestion of food), while still restricting
the volume of the pouch P. FIG. 4D depicts the organ division of
FIG. 4C as a transparent section to further depict the cross
section of the resulting division (pouch "P") created by fastening
line 430 at section line S.
[0039] FIG. 4E depicts a further configuration of fastening lines
430, creating partitions within the organ for forming a restriction
or pouch P. By using several fastening points or lines within the
organ that fan out, intake can be restricted while still allowing
the organ to function. Similarly FIG. 4F depicts the organ division
of FIG. 4E as a transparent section to further depict the cross
section of the resulting division (pouch "P") created by fastening
line 430 at section line S. In yet another embodiment of the
present invention, FIG. 4G depicts the placement of one fastening
line 430 close to the GEJ and substantially parallel to the lesser
curve of the stomach (LC) thereby forming a pouch or partition
excluding the section of stomach below the esophagus from the
majority of the stomach organ. An additional fastening line 450 may
also be formed at or near the outlet of the pouch or partition, by
either creating an additional dual fold fastening line to create a
stoma, or by just acquiring one tissue fold, either the anterior or
posterior wall of the stomach to create a pleat 460, thereby also
narrowing the outlet or creating a stoma. Such a division and
single fold tissue pleat 460 are depicted in FIG. 4H showing a
transparent sectioning of a divided stomach.
[0040] It is anticipated that the placement of fastening lines 430,
may vary from those depicted herein, as is necessary for a
physician to achieve a desired clinical effect, or to overcome
variations in the anatomy of the patient. Such configurations that
utilize the methods and devices of the present invention are
contemplated to be within the scope of this disclosure. In
addition, a fastening line 430 as referred to herein, may be a line
of fastening elements placed simultaneously or serially until the
desired result is achieved. They may also be in the form of a clamp
or other fastening element, as described herein, or as known in the
art for securing tissue together.
[0041] FIGS. 5, 6 and 7 depict cross sectional schematic views of
the procedure of the present invention from the perspective of the
tissue being manipulated. In FIG. 5, the posterior wall of the
stomach (PW) and the anterior wall of the stomach (AW) are shown in
the configuration they will take once the tissue acquisition device
of the present invention has been activated (device not shown for
clarity). Tissue layers represented are the serosal layer (SL), the
muscularis or fibrous muscular layer (ML), and the mucosal layer
(MUC). One feature of the present invention is to acquire the
tissue such that it is positioned with a certain amount of fibrous
tissue overlap (Overlap) prior to fastening in a configuration akin
to a lap joint. The amount of the overlap can vary and needs only
to be sufficient enough to result in healing of the fastened
sections, thereby creating a tissue bridge (TB) along the length of
the fastened tissue. Said tissue bridge may be formed of various
layers of the stomach and may include scar tissue and other
elements of effective wound healing.
[0042] In addition, it may be advantageous to further approximate
the Overlap section by clamping the tissue to be fastened as
depicted in FIG. 6. When clamps 610 applies a clamping force to the
overlapped section, the less fibrous lining of the stomach, the
mucosa (MUC), is compressed and squeezed thin to minimize its
presence within the fixation zone. In doing so, the fibrous
muscularis and serosal layers that are more responsive to healing
can be more closely approximated. Finally, FIG. 7 illustrates the
formation of a tissue bridge (TB) between the two tissue folds,
demonstrating that each pouch or lumen is re-paved with mucosal
tissue and fasteners are covered by mucosa such that only the
mucosa is exposed to the acids of the stomach, but the tissue
bridge itself is formed of the various fibrous tissue layers,
including scar tissue.
[0043] Devices
[0044] FIG. 12 shows the tissue acquisition device 120 of the
present invention having a proximal and distal end and a main lumen
121 therebetween. Device 120 has a handle portion 122, and a main
body portion 123 having one or more lumens (not shown) and
terminating in a distal end, said distal end preferably segmenting
into first and second jaw members 124 and 125 respectively, each
jaw member having a tissue acquisition port 132 housed therein.
Each port 132 is in fluid communication with one of the lumens of
the main body portion 123 and connected to filler port 133 located
on handle portion 122.
[0045] Main body portion 123 may be bendable, having a shaft made
of resilient plastic such as polyurethane, silicone, PVC or a
laminate all optionally reinforced with a wire, or made of a
composite construction of more than one material, or articulable,
such as formed of a slotted tube connected to a pull wire in the
proximal handle (not shown), to allow the operator to achieve
flexion of the main body portion or distal tip by operating the
pull wire. Such flexibility allows for smooth introduction down the
esophagus and into the stomach, as well as optimal positioning
within the stomach prior to tissue acquisition. In addition, handle
portion 122, preferably includes a main port 126, through which
various devices such as an endoscope or fastening assembly of the
present invention may be passed to monitor and complete the
procedure of the present invention.
[0046] It may be necessary or desirable to employ a further
tensioning mechanism at device 120 distal end to assist the use of
vacuum to acquire the desired tissue. The embodiment depicted in
FIGS. 12A and 12B, shows first and second hinging members 130 and
131, respectively, formed as part of main body 123 and connected to
each of distal end jaws 124 and 125. Hinging members 130, 131 can
be formed in multiple ways, but are shown in FIG. 12 as being
formed by two crescent shaped cutaways 134 spaced longitudinally
along the shaft of main body 123 and at 180 degree rotations from
one another. In operation, a lever 127 is pivotally connected to
the main handle body 122 by pin 135. Pull cables 128 (only one
shown) are fixedly connected to lever 127 and jaws 124 and 125 such
that when lever 127 is deployed jaws 124 and 125 separate in a
scissoring motion as depicted in FIG. 12B. Actuation of hinging
members 130 and 131 act to further tension the tissue already
acquired in vacuum ports 132 and ensuring the fixation zone (FZ)
includes the appropriate amount of serosal overlap as depicted in
FIG. 12C. Optional guide rods 136, may be affixed to jaws 124 or
125 or both, to assist in tissue tensioning and manipulation
(tissue shown here as T).
[0047] FIG. 13 depicts a more detailed showing of the jaws 124 and
125 of tissue acquisition device 120, including an alternative
embodiment of a guide rod mechanism. Each jaw (124, 125) is
equipped with a vacuum port 132, each located at 180 degrees from
the other to allow tissue to be acquired from opposite sides of the
organ while allowing the maximum axial depth within the jaw body.
Port opening 132 may extend approximately 1 inch longitudinally
along the jaw body, and approximately 0-5 cm into the jaw body,
depending on the amount of tissue to be acquired (dotted lines
depict various depths of the port). It is also within the scope of
the present invention for such vacuum ports 132 to be configured in
the form of suction cups, or formed of fenestrations within the
jaw. Vacuum ports 132, are in fluid communication with tubes 138A
and 138B, which run the length of the tissue acquisition device
main body, and terminate at filler port 133 as earlier described to
allow vacuum to be activated at the ports. In this alternative
embodiment, each jaw (124, 125) is equipped with a guide rod 137A,
137B consisting of a rigid bar members affixed to respective tubes
138A and 138B proximal of the communication between the tubes 138A
and 138B and each respective jaw body, and further curved to extend
longitudinally along the jaw body 180 degrees from port opening 135
on respective jaws. Guide rods act as a stay to further assist in
tissue manipulation and tensioning. This embodiment functions
similarly to that already described in FIGS. 12, 12A and 12B.
[0048] FIG. 14 shows yet another embodiment of the distal end of
the tissue acquisition device of the present invention,
incorporating both the hinging members 130, 131 (not shown) of FIG.
12, and an additional mechanical post 145 inserted down the lumen
of tissue acquisition device 120 once tissue has been acquired in
vacuum port 132, but prior to activating the hinging members 130,
131, to act like a skewer and further secure the acquired tissue in
place.
[0049] In some cases, the jaws 124, 125 and preferred tensioning
mechanism of tissue acquisition device 120 are adapted such that
the insertion of fastening assembly 150 through the distal end of
tissue acquisition device 120, activates (by spreading or
displacing) the tensioning mechanism. This passive activation of
the tensioning mechanism obviates the need for additional pull
wires, cables or levers to control the tensioning process. It is
also within the scope of the present invention that the tensioning
mechanism involves twisting of the tissue folds once they are
approximated by the tissue acquisition device.
[0050] FIG. 15 shows fastening assembly 150, consisting of a
fastening assembly handle 151, fastening assembly main body 152,
and fastening assembly clamping portion 153, having clamping jaws
154A and 154B. FIG. 15A depicts fastening assembly clamping portion
153 in an open configuration (its default setting). In use, handle
151 is slightly engaged to bring jaws 154A and 154B of clamping
portion 153 together such that fastening assembly 150 can be
inserted into the main port 126 of tissue acquisition device 120.
Once inserted, FIG. 16 depicts placement of jaws of fastening
assembly inserted within distal end of tissue acquisition device
120 (distal end shown in dotted line configuration). Following
insertion of the fastening assembly down the main lumen 121 of the
tissue acquisition device 120, fastening assembly handle 151 is
actuated to fully engage jaws 154A and 154B into acquired tissue T.
Once tissue is clamped, fastening elements can be deployed into the
clamped tissue (fixation zone (FZ)) as further described below.
[0051] FIGS. 17-18 show various embodiments of fastening elements
deployed by the fastening assembly of the present invention. FIG.
17 depicts an implantable clamp member 170, including a penetrating
clamp portion 171 having post portions 175, and a receiving clamp
portion 172, having receiving members or holes 176 adapted for
interface with posts 175. One or other of said clamp members may
include a patterned or protruding surface on tissue engaging
surface 174 to lessen the potential for tissue necrosis and aid in
healing. In addition, tissue engaging surface 174 may include
spikes or other penetrating elements (not shown) to minimize
slippage while clamping. In further embodiments, implantable clamp
member 170 may be formed in a curved configuration to assist in
creating optimal pouch geometry. Further, implantable clamp member
may be formed of various materials that are either permanent or
biofragmentable such as Delrin.RTM., polyglycolic acid, lactomer,
polyester, polydiaxinon, steel, titanium or NiTi.
[0052] In operation, penetrating clamp portion 171 and a receiving
clamp portion 172 would be loaded into the respective jaws of
fastening assembly 150 prior to insertion of the fastening assembly
into the tissue acquisition device, and deployed into the acquired
tissue upon clamping of the fastening assembly onto the deployed
tissue. It should be further noted that penetrating clamp portion
171 and a receiving clamp portion 172 may be deployed as two
separate pieces, or may be hingedly connected in a similar fashion
to the clamp jaws 154A and 154B of the fastening assembly 150.
[0053] FIG. 18A depicts fastening elements 180 consisting of
discrete rivets having a penetrating rivet portion 181, having a
post portion 183 and a body portion 184, and a receiving rivet
portion 182, having a receiving element 185 and a body element 186.
Such rivets can be formed of materials that are either permanent or
biofragmentable such as Delrin.RTM., polyglycolic acid, lactomer,
polyester, polydiaxinon, steel, titanium or NiTi, and can be
deployed in parallel with other rivets or sequentially, depending
on the desired outcome. FIG. 18B depicts the fastening element of
the present invention in it's deployed state. As shown in FIG. 19,
fastening elements or rivets may be coupled with a material 190 to
assist in tissue ingrowth and healing. Such materials may be
meshes, grafts, microporous membranes or biomaterials such as
collagen or porcine biointestinal submucosa (Biosis.RTM., Cook,
Inc.) In operation, such materials may either be adhered to the
fastening element, or provided as a separate element to be placed
within the fastening assembly jaws prior to clamping and deploying
fastening elements.
[0054] FIGS. 20A and 20B represent depictions of the final result
of tissue fold fixation contemplated by the present invention
showing a perspective view of the inside of the restricted organ
and the resultant fixation zone, using fastening elements 201 or
202 respectively. Although various embodiments have been disclosed,
it is contemplated by this description of the devices used for
creating the pouch of the present invention, that the fastening
assembly will be a flexible endoscopic stapler and that the
fastening elements will be staples, preferably formed of titanium
or steel, but it is within the scope of this method to use any of
the fastening devices disclosed herein to accomplish the same
result.
[0055] Method of Hollow Organ Volume Reduction
[0056] A clinical work-up, including a physical and mental
assessment of the patient may be performed to determine whether a
transoral stomach reduction clinically indicated. This assessment
may include inspecting the esophagus and stomach of the patient to
determine whether any contraindications exist for undertaking the
procedure such as ulcerations, obstructions, or other conditions
that may preclude treatment. Once the procedure has been determined
to be appropriate, as depicted in FIG. 8, either in an operating
room with the patient under general anesthesia, or in an endoscopy
suite with the patient under sedation, the operator can introduce
tissue acquisition device 810 down the patient's esophagus and into
the stomach to a location just beyond the GE Junction. Once in
place, an optional calibration device 820, such as a balloon or
bougie can be inflated or deployed to assist in correctly sizing
the pouch to be created. The operator may gently pull on the tissue
acquisition device 810 until the calibration balloon contacts the
GEJ. The operator can determine, by tactile feedback (resistance)
as the calibration balloon snugs up against the GEJ and esophagus,
where to place the tissue acquisition device to optimally position
it longitudinally between the GEJ and the LC. Alternatively, the
physician may opt to use direct vision and place an endoscope
through the main lumen of the tissue acquisition device to view the
site of entry and resultant treatment zone.
[0057] The operator may then orient the tissue acquisition device
axially to ensure that the vacuum ports of tissue acquisition
device, once activated, will contact the anterior and posterior
regions of the stomach thereby acquiring tissue in the appropriate
configuration to create the desired pouch or partition. This is
done by aligning an indicator emblem (not shown) with, e.g., the
patient's nose (patient should be lying on his or her back with
nose pointed directly at the ceiling). The endoscope, if still
inserted, can be removed and the distal end of the tissue
acquisition device can be articulated to approximate the ultimate
fixation zone, and locked or otherwise secured in place (See detail
in FIGS. 8A and 8B). The operator may then attach a vacuum source
similar to the wall suction units found in general operating suites
(not shown) to the filler port of the tissue acquisition device,
checking to make sure that the vacuum source is delivering
approximately 600 mm/hg vacuum. The operator may then open the
tissue acquisition device stopcock to allow vacuum pressure to
develop in the lumens attached to the vacuum ports. As depicted in
FIGS. 9 and 9A, tissue folds will begin to invaginate within the
vacuum ports 132 and into the main lumen of the tissue acquisition
device. Once vacuum pressure has stabilized (i.e. a seal has
developed between the device and the tissue), if desired, a
mechanical tensioning mechanism of the present invention can be
actuated to assist in mechanical tissue acquisition as earlier
described. At this point, the operator may want to reinsert the
scope to confirm that the tissue folds are equally within the
vacuum ports and that the tensioning members are holding the folds
consistent with the schematic depiction in FIG. 10. FIG. 10 depicts
an end on view of the main lumen of tissue acquisition device 810,
including guide posts 840 and vacuum ports 830. Tissue T is
approximated and read to be secured by a fastening component of the
present invention.
[0058] Once this is confirmed, the operator may insert the
fastening assembly of the present invention through the main lumen
making sure to align the fastening assembly with an indicator on
the tissue acquisition device indicating that the jaws of the
fastening assembly are passing on either side of the approximated
dual folds of tissue within the tissue acquisition device main
lumen as previously described and depicted in FIG. 16. The
fastening assembly will snap into place with the tissue acquisition
device at the correct alignment. As noted previously, to accomplish
the correct placement of the jaws around the tissue, the operator
may deploy the fastening assembly handle to close the jaws
sufficient to pass on either side of the acquired tissue. Once in
place, the operator-may deploy the fastening assembly handle to
clamp the jaws down on the acquired tissue. As referenced earlier,
the clamping function, followed by the firing of the fasteners,
allows the system to apply sufficient force to the acquired tissue
to flatten the tissue to be fastened so that the critical external
stomach layers (muscularis and serosa) of both tissue folds are
contained within the fixation zone and mucosal tissue is minimized
within this zone.
[0059] Following the clamping, the operator may then actuate the
handle 151 of fastening assembly 150 to deploy fastening elements
through the acquired tissue. Once fasteners are deployed, the
operator may disengage the actuation mechanism to back off the
fastener driver mechanism (not shown). Similarly, the operator may
then disengage the clamp jaws of the fastening assembly, unclamping
the fastened tissue folds. If utilized, the calibration balloon can
then be deflated and the tissue acquisition device and fastening
assembly can be withdrawn from the patient. The operator can then
redeploy the endoscope to inspect the resultant pouch. The end
result of the procedure is schematically depicted in FIG. 11,
including a cross section of the stomach prior to reduction (FIG.
11A), a cross section of the stomach post reduction (FIG. 11B)
showing pouch lumen P, and an internal view of the fixation zone
(FZ) within the greater geometry of the stomach organ (FIG.
11).
[0060] The steps of performing the method of the preferred
embodiment of organ division or reduction (transoral stomach
reduction) are used to illustrate in detail the method of the
present invention, however the present invention is not limited
thereby. Use of these steps and the tools deployed therein may be
varied to achieve a similar result in other hollow body organs and
it is anticipated that such techniques can be employed to divide or
restrict other hollow body organs such as organs of the
gastrointestinal tract such as bowel, stomach or intestine,
bladder, uterus, and heart (such as in ventricular reduction or
treatment of chronic heart failure). In addition, as previously
mentioned, other procedures such as the treatment of GERD may also
benefit from the methods and devices disclosed herein. While
certain embodiments have been illustrated and described in detail,
those having ordinary skill in the art will appreciate that various
alternatives, modifications, and equivalents may be used and that
the invention is not intended to be limited to the specifics of
these embodiments.
* * * * *